Bausch Health

  • Sr. Manager, Global Pharmacovigilance & Risk Management

    Location US-NJ-Bridgewater
    Job ID
    11174
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Provides input in signal identification & evaluation

     

    Provides Medical review of aggregate reports (PSUR, PADER, PBRER)

     

    Prepares & reviews DSURs for timely submission to the regulatory authorities

     

    Active participation & input in preparation of the REMS for USA products

     

    Provides assistance in RMPs as needed

     

    Provided medical review of ICSR including causality assessment

     

    Reviews safety information on Labels via ELM

     

    Provides safety input on protocols, CSRs, IB and informed consent

     

    Provides medical input on AE, Conmed, Medical history listings including SAE reconciliation

     

    Prepares Health hazard evaluation for post marketed products

     

    Maintains the database  (Ag balance)

    Responsibilities

    Supervised, coordinated, and provided scientific guidance to Safety Surveillance and Risk Management teams for signal detection, signal management and safety governance including tracking of those activities, and teams training on signal detection and management

     

    Prepared and presented individual cases to the external & internal expert panel for the REMS Safety board meeting

     

    Global medical evaluation and documentation of SAEs and AESIs in clinical trials.

     

    Provided review and safety updates on NDA, IB, CSR, protocols and IND reports

     

    Authorized, prepared and review of aggregate reports including DSURS for timely submission to the regulatory authorities

     

    Review aggregate reports including PADER, PBRER and PSUR of various products.

     

    Provided review of company RSI including updates to the CCSI

     

    Prepared and participated in CAPA meetings for Health Hazard Evaluation (HHE) of various pharmaceutical products and medical devices.

     

    Prepared and assessed detail health hazard evaluation for post marketed products

     

    Provided medical review and assessment of ICSR which includes causality assessment, narratives for CSR submission, and safety review for various trials in various phases

     

    Provided expertise on safety data on Labels (OTC and Prescription) and safety information on labels using ELM

     

    Other activities included providing key input for the review of new or ongoing safety documents that ensure compliance with domestic and international regulatory requirement that include, but may not be limited to, protocols, regulatory reports.

     

    Other duties involved periodic SOP updates, periodic updates to HHE forms and other safety related forms

     

    Mentored and trained drug safety teams on signal detection, health hazard evaluation, database training, clinical data review of patient profiles, adverse events, concomitant medication and medical history

     

    Provides input and maintains the database (Ag balance) for timely execution of queries (monthly, quarterly & annual)

     

    Per the FDA guidelines, provides PLRR updates to the assigned products

     

    Provides input and follow-ups on DME alerts.

     

    Maintains DME tracker

     

    Medical review Team lead which includes HHE, DME Alerts, Clinical safety

     

    Distribution of Aggregate reports and signal queries regularly.

     

    Cortellis Intelligence Alerts maintenance

     

    Qualifications

    Degree in Medicine (MD) (preferred)

     

    Professional competency:

    Knowledge of database management & use of coding dictionaries

    Knowledge of ArisG, Ag signals, Ag balance and Inform database

    High Level of computer literacy (Microsoft word, Excel, Powerpoint, Outlook and Adobe Acrobat

    Clear, effective written & verbal communication skills

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